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NCT Number: NCT05765994

Small Intestinal Bacterial Overgrowth in Critically Ill Patients

Small intestinal bacterial overgrowth (SIBO) syndrome, though associated with potentially serious complications, has not been adequately studied to date in critically ill patients hospitalized in intensive care units (ICU).

A modified method for SIBO diagnosis is employed concerning a standard breath test. Specifically, as all participants are intubated and in need of mechanical ventilation, SIBO diagnosis is based on a non-invasive modified technique for sampling exhaled air from the ventilator tubes and performing a standard hydrogen breath test.

The primary objective of this study is assessment of the prevalence of SIBO on ICU patients. Secondary outcomes include investigation of the effects of SIBO on ventilator associated pneumonia, as well as ICU length of stay and all-cause in-hospital mortality rate in critically ill patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Univesity Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

About this study

Small intestine bacterial overgrowth (SIBO) remains to this day a syndrome that is not fully understood. Initially, it was considered quite rare, but today there are reports suggesting a SIBO prevalence between 6 to 15% of healthy, asymptomatic people and reaching 80% in patients with irritable bowel syndrome. It is often involved in various disorders, such as diarrhea and malabsorption. It is defined as an increase in the number and/or disturbance in the type of bacteria in the upper part of the intestinal tract.

SIBO occurs when the homeostatic mechanisms of the small intestine are disturbed. The two main conditions that favor microbial overgrowth in the small intestine are decreased acid secretion from the stomach and small bowel dyskinesia.

The literature is scarce concerning the effects of SIBO on critically ill patients. To our knowledge this is the first study investigating the effects of SIBO on mechanically ventilated patients. It is a non-invasive observational study employing a modified technique to obtain exhaled air from the ventilator tubes to perform a standard hydrogen breath test for SIBO diagnosis. Lactulose is used as a substrate. Specifically, each patient is administered 20 g of lactulose diluted in 400 ml of water through the nasogastric tube. Measurements are performed at 0-15-30-45-60-90-120-180 min from lactulose administration. During measurements, a valve attached to a collecting bag at the end of the expiratory limb of the breathing circuit, is kept open and the collecting bag is filled by several patient exhalations. After valve closure and bag isolation, the air is drawn by a 50 ml polyethylene syringe which is connected to the valve system to prevent losses and/or contamination. Then the air is blown into the breath hydrogen monitor and the expired hydrogen measurement is recorded.

The hydrogen breath test is repeated at predetermined, protocol-based time intervals for all participants included in the study; 1st/day of admission, 3rd, 5th and 7th day of ICU stay. The 1st day measurement serves as a measure of eligibility, and patients exhibiting abnormal values of hydrogen breath testing at Day 1 are excluded from the study.

An increase by more than 20 ppm of eH2 from baseline within 90 min was considered an abnormal measurement suggesting SIBO. Moreover, an increase by more than 12 ppm of eH2 from baseline within the first 30 minutes followed by a second rise within the next 15 minutes (double peak) was also considered an abnormal measurement suggesting SIBO.

The primary objective of this study is assessment of the prevalence of SIBO on critically ill mechanically ventilated ICU patients. Secondary outcomes include investigation of the effects of SIBO on ventilator associated pneumonia, as well as ICU length of stay and all-cause in-hospital mortality rate in critically ill patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • critically ill patients, in need of mechanical ventilation with an expected ICU length of stay and expected mechanical ventilation duration of more than 48 hours

Exclusion criteria

  • abnormal hydrogen breath test on the day of ICU admission (Day 1)
  • recent (up to four weeks before ICU admission) antimicrobial therapy or patients already receiving antimicrobial therapy on admission
  • recent (up to four weeks before ICU admission) use of gastroprotective medication, probiotics and prokinetics
  • patients with known gastrointestinal disease prior to admission
  • recent abdominal surgery resulting in planned or unplanned ICU admission
  • extubation or death before protocol completion (7 days) constitute exclusion criteria after enrollment

Treatment and study plan

Modified hydrogen breath test

Diagnostic Test

A modified technique to obtain expired hydrogen from the ventilator tubes is performed. A connection with a valve attached to a collecting bag is inserted at the end of the expiratory limb of the breathing circuit for exhaled air collection.

Other names: Hydrogen monitor Gastrolyzer / Gastro+TM (Bedfont® Scientific Ltd,) was used for expired hydrogen (eH2) testing.

Primary outcomes

  1. SIBO prevalence

    Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)

    The proportion of ICU patients diagnosed with SIBO

Secondary outcomes

  1. VAP (ventilator associated pneumonia)

    Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)

    The proportion of ICU patients diagnosed with VAP

  2. ICU LOS

    Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)

    ICU lenght of stay, days

  3. All-cause in-hospital mortality

    Time frame: From date of ICU admission to date of ICU discharge or date of death from any cause, whichever came first, assessed up to one month)

    Death due to any cause during ICU and hospital stay.

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

The Effects of Small Intestinal Bacterial Overgrowth Syndrome in ICU Patients. An Observational Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2023
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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